1. What is the procedure for the registration of pharmaceutical products?
For traditional/poison/non-poison (OTC) /food supplement:
Currently, only on-line submission is accepted for product's registration. This could be done by through NPCB's website www.bpfk.gov.my. An applicant must buy a membership for Quest2 before the applicant can proceed with registration. There are several packages available to choose to become a member of Quest2. Any assistance/advice shall be forwarded to Digicert Customer Service Department: 03-89961600. Once the applicant has received the user and password from Digicert, he/she will be able to enter the registration site and proceed with online submission. This online registration system is also applicable for traditional registration, re-registration of products and licensing.
The summary of the online registration procedure for products are as follows:-
1) Go to NPCB website (www.bpfk.gov.my)
2) Become Quest2 member (as First-time User)
* Requirements:
i. Company Registration Form
ii. Company Authorization Letter
iii. Photocopy of I/C
3) After making payment to Digicert, within 7 working days (
4) With the login name and password, enter Quest2, go under registration, and register the product on-line. All forms are available in the form tray.
5) Submit data requested
6) Correspondences with NPCB officer if additional data is needed
7) Products tabled to DCA meeting
8) Product is registered For New Chemical Entity/Biotech products:
Registration is still manually submission, meaning that your registration process is divided into 3 stages as below :
Stage 1 - Submitting letter of intent with certain particulars pertaining to the product.
Stage 2 - Following approval of stage 1, samples of the product will be requested for laboratory analysis.
Stage 3 - Submission of complete documents pertaining to the product for full evaluation.
2. Processing fee
Every application for registration shall be accompanied with a processing fee, as follows (effective January, 2007) :-
| No | Product Classification | Processing Fees (RM) | Analysis Fees (RM) | Total Fees (RM) |
| 1 | New Chemical Entity | 1,000.00 | Single active ingredient : 3,000.00 | 4,000.00 |
| Two or more active ingredients : 4,000.00 | 5,000.00 | |||
| 2 | Pharmaceutical | 1,000.00 | Single active ingredient : 1,200.00 | 2,200.00 |
| Two or more active ingredients: 2,000.00 | 3,000.00 | |||
| 3 | Traditional | 500.00 | 700.00 | 1,200.00 |
Applications without the correct fees will not be accepted. Foreign currencies are not acceptable. The processing fee is NOT REFUNDABLE.
Other charges
The DCA will charge any applicant such costs as it may incur for the purpose of carrying out laboratory investigations/ testing prior to the registration of any product.
Mode of Payment
The processing fee and any other charges shall be paid in the form of a bank draft/money order made payable to "Biro Pengawalan Farmaseutikal Kebangsaan".
NB. A separate bank draft is required for each application for registration.
3. What is the next step to take after my product is registered?
After a product is registered, the applicant must apply for a manufacturer/ import/ wholesale license.
The processing fees are as below:
| Licence | Registration fee | Time line * | Validity |
| 1. Import licence | RM 500 | Not more than 1 month | 1 year |
| 2. Manufacturer | RM 1000 | Not more than 1 month | 1 year |
| 3. Wholesaler | RM 500 | Not more than 1 month | 1 year |
4. What is the timeline (time-frame) for registration?
The duration for each product to be registered is calculated from the date of final and complete submission.
Below are the timeline for product of each category:
| Category of product | Timeline |
| | Full Evaluation |
| Prescription & Non- prescription (Non-poison) Drugs (online) | 12 months |
| New Drugs & Biologicals (manual submission,3rd stage) | 12 months |
| Category of product | Abridged Evaluation |
| Health Supplement Products | 6 months |
| Natural Product (Traditional) | 6 months |
| Non- prescription drug | 6 months |
5. How can an overseas company register and distribute its product in
All pharmaceutical products must be registered with the Drug Control Authority before it can be marketed in
There are specific forms to complete during the process of registration and under the labeling requirements for products registered with the Drug Control Authority, the name and address of the actual manufacturer must be declared on the label.
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